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ImportanceUltrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important.ObjectiveTo characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy.Data SourcesA Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials.Study SelectionTrials with similar designs, standardized operational implementation (medication standardization and blinding of both patients and physicians to treatment assignment), and follow-up.Data Extraction and SynthesisPooled analysis using individual patient-level data using linear regression models to compare uRDN with sham across the trials.Main Outcomes and MeasuresThe primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic BP (dASBP) between groups.ResultsA total of 506 patients were randomized in the 3 studies (uRDN, 293; sham, 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, −5.9; 95% CI, −8.1 to −3.8 mm Hg; P < .001 in favor of uRDN). BP decreases from baseline with uRDN vs sham were consistent across trials and across BP parameters (office SBP: −10.4 mm Hg vs −3.4 mm Hg; mean difference, −6.4 mm Hg; 95% CI, −9.1 to –3.6 mm Hg; home SBP: −8.4 mm Hg vs −1.4 mm Hg; mean difference, −6.8 mm Hg; 95% CI, −8.7 to −4.9 mm Hg, respectively). The BP reductions with uRDN vs sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety end points were observed between groups.Conclusions and RelevanceResults of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups.Trial RegistrationClinicalTrials.gov Identifier: NCT02649426 and NCT03614260

Color Doppler by transthoracic echocardiography creates two-dimensional fan-shaped maps of blood velocities in the cardiac cavities. It is a one-component velocimetric technique since it only returns the velocity components parallel to the ultrasound beams. Intraventricular vector flow mapping (iVFM) is a method to recover the blood velocity vectors from the Doppler scalar fields in an echocardiographic three-chamber view. We improved our iVFM numerical scheme by imposing physical constraints. The iVFM consisted in minimizing regularized Doppler residuals subject to the condition that two fluid-dynamics constraints were satisfied, namely planar mass conservation, and free-slip boundary conditions. The optimization problem was solved by using the Lagrange multiplier method. A finite-difference discretization of the optimization problem, written in the polar coordinate system centered on the cardiac ultrasound probe, led to a sparse linear system. The single regularization parameter was determined automatically for non-supervision considerations. The physics-constrained method was validated using realistic intracardiac flow data from a patient-specific CFD (computational fluid dynamics) model. The numerical evaluations showed that the iVFM-derived velocity vectors were in very good agreement with the CFD-based original velocities, with relative errors ranged between 0.3 and 12%. We calculated two macroscopic measures of flow in the cardiac region of interest, the mean vorticity and mean stream function, and observed an excellent concordance between physics-constrained iVFM and CFD. The capability of physics-constrained iVFM was finally tested with in vivo color Doppler data acquired in patients routinely examined in the echocardiographic laboratory. The vortex that forms during the rapid filling was deciphered. The physics-constrained iVFM algorithm is ready for pilot clinical studies and is expected to have a significant clinical impact on the assessment of diastolic function.